Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged.
EXPERIENCE:
Required: At least five years of prior experience in clinical research as a Clinical Research Coordinator and/or Study Monitor required.
Experience with IRB administration and data management.
Preferred: Supervisory experience grant writing experience
EDUCATION:
Required: Bachelors Degree
Preferred: Masters Degree
CERTIFICATIONS:
Required: CITI
Preferred: GCP
COMPETENCIES:
Understanding of clinical research methodology and regulations is essential. Experience in clinical trial coordination study monitoring and project management required. Leadership skills good presentation and writing skills as well as the ability to lead interact well with others take initiative and think independently are also required.
SUPERVISORY RESPONSIBILITY:
Direct: Supervises and trains research coordinators and assistants number will depend on active ongoing clinical trials.
FISCAL RESPONSIBILITY:
Monitors study payments and expenditures.
SUMMARY:
Receiving general direction from the PI and Clinical Research Program Manager the Project Managerwill coordinate all activities necessary to launch conduct and close out the clinical trials and other projects of the Center for Vascular Emergencies (CVE) . The CVE is dedicated to improving the care of patients with life threatening vascular diseases through coordinated educational research and quality improvement initiatives within the Department of Emergency Medicine.To ensure timely completion of project goals the CVE Project Manager will interface and collaborate with the study site P.I.s and all levels of study staff at each participating hospital.
This is a fulltime 40 hours/week) position; evening hours and weekend hours will be required. Studies may require staff to be oncall one weekend and 5 weeknights a month. The ability of the successful candidate to take call is preferred.
MAJOR DUTIES:
Major duties include:
Establishes and monitors timelines and benchmarks for study implementation recruitment and completion
Coordinates and supervises efforts for all studies and provides guidance to the study specific staff in protocol implementation meeting recruitment goals performing clinical procedures and managing data collection
Establishes recruitment strategies and assures implementation and goal attainment on trials and other funded research
Monitors study performance for subject accession and data acquisition in accordance with the protocols and conveys information to Clinical Research Program Manager and PIs
Serves as primary resource for all regulatory and operational aspects of the site overseeing submission and maintenance of documentation to the IRB and sponsors
Organizes facilitates and implements operational meetings training seminars and studyspecific team meetings
Interacts directly with study sponsors the NIH other clinical sites the Clinical Coordination Center and the Data Coordination Center
Designs and implements quality assurance systems to assure compliance
Ensures compliance with applicable trial FDA NIH and other regulatory agencies requirements
Develops and maintains standard operating procedures
Oversees collection and integrity of trial data
Fields study staff questions on a day to day basis
Meets regularly with all study PIs Clinical Research Program Manager and coordinators
Assists with audit preparation as necessary
Accepts responsibilities for special projects as requested
May also perform duties of Senior Clinical Research Coordinator
May provide assistance writing and submitting grant applications
WORKING CONDITIONS:
Works in an office setting and in the clinical environment of the Emergency Department. May be required to attend and travel to meetings outside of regularly scheduled hours. You must be available by pager/cell phone outside of normal business hours. May be required to report to the hospital outside of normal business hours to assist with events that require emergency management.
Emergency Department CVE CLINICAL RSCH PROJ MGR
